Drug Evaluation Committee Issues in Survival Time Analysis in Cost-Effectiveness Assessment
Data Science Subcommittee
February 2020
The ICER is defined as the additional cost per unit of additional benefit brought by a new drug, where the benefit is evaluated in terms of quality-adjusted life years (QALYs). The principle of this system is that effectiveness is evaluated in terms of QALYs (Quality-Adjusted Life Years). For drugs whose clinical efficacy is evaluated in a clinical trial using a survival analysis, it is highly likely that the ICER calculation in a cost-effectiveness analysis will be performed in the context of the relevant survival analysis. In cost-effectiveness analysis, cost-effectiveness analysis is conducted over a longer period of time than the follow-up period of the clinical trial to make decisions that are considered optimal (i.e., whether to adjust the price of a new drug and, if so, how to do so). Because of this characteristic of cost-effectiveness analysis, in which the superiority of a drug is determined by estimation rather than testing, it is often necessary to present data "as if" one had seen something one did not see. Specifically, if a clinical trial has a follow-up period of 3 years but a survival curve over 15 years is estimated by extrapolation, or if control group cases are allowed to switch to a new drug after disease progression, it is necessary to estimate the overall survival of the control group when many cases switch to the new drug using causal inference
In the 2019 DS Subcommittee Continuation T5, the UK NICE publication Technical Support Document 14 (TSD14): Survival analysis for economic evaluations alongside clinical trials - extrapolation with patient-level data (2011), TSD16: Adjusting survival time estimates in the presence of treatment switching (2014) and TSD19: Partitioned Survival Analysis as a decision modelling tool (2017), the report summarizes the survival time analysis techniques used in cost-effectiveness analysis and the challenges specific to cost-effectiveness analysis related to these techniques. The report was prepared.
The references/references to Technical Support Documents 14, 16, and 19 (Decision Support Unit, National Institute for Health and Care Excellence) in this report are the Task Force's NICE is not responsible for any of these references. Not all of the TSDs were introduced, but rather a selection of them. The Task Force's additional interpretations were added and summarized independently, and no views were obtained from NICE.
Issues in Survival Time Analysis in Cost-Effectiveness Assessment (1.8MB)
Deliverables of the Drug Evaluation Committee Return to list of all deliverables